相关临床试验
46
2 进行中
药物批准
27
批准总数
监管机构
1
监管机构数
成立时间
1949
已完成
34
73.9%
尚未招募
2
4.3%
招募中
10
21.7%
- Ipca Laboratories and BioSimilar Sciences PR LLC announced a definitive technology transfer and joint development agreement for next-generation monoclonal antibody biosimilars targeting cancer and autoimmune diseases. - The partnership will transfer late-stage development, clinical manufacturing, and commercial supply to BSS's 200,000-square-foot sterile facility in Puerto Rico, with the first biosimilar launch planned for 2027. - BSS will hold exclusive rights for the US and Canada markets, while Ipca will receive milestone fees and royalties on net sales once commercialized. - The collaboration leverages OcyonBio's sterile filling capacity of 60 million units annually and is expected to create hundreds of high-paying biotech jobs in Puerto Rico.
- The FDA quietly permitted more than 150 exempted products from officially banned foreign factories to continue shipping to the United States for over a dozen years to prevent drug shortages. - ProPublica's investigation revealed that most exempted drugs came from factories in India, with additional facilities in China and Hungary, despite dangerous manufacturing failures that led to import bans. - The agency did not regularly test these exempted drugs or proactively monitor safety reports describing products with foul odors, abnormal taste, or consumers experiencing unexplained health problems. - Several factories remain banned but continue receiving exemptions, while the FDA kept this practice largely hidden from the public without releasing a comprehensive list until now.
